Novel radiofrequency-based treatment achieves skin tightening with minimal discomfort

February 21, 2005

Functional Aspiration Controlled Electrothermal Stimulation (FACES) appears to be a safe, effective, and very well-tolerated technique for reducing the appearance of wrinkles, reported Michael H. Gold, M.D.

Functional Aspiration Controlled Electrothermal Stimulation (FACES) appears to be a safe, effective, and very well-tolerated technique for reducing the appearance of wrinkles, reported Michael H. Gold, M.D.

In this procedure, the skin is aspirated with suction into a specially designed handpiece where it is held between two parallel electrodes and then treated with a high-frequency electrical current.

Dr. Gold in collaboration with Mitchel Goldman, M.D., performed a two-center study evaluating this investigational modality (Aluma, Lumenis) for full-face treatment in a total of 46 subjects (mean age 52 years). Thirty-six participants completed the planned course of eight treatments, 34 were evaluated at 1 month post-treatment, and 19 patients were seen so far at the 3-month, post-treatment follow-up. The planned duration of follow-up is 6 months after the last session.

Investigator-rated elastosis scores showed gradual improvement in upper and lower face wrinkles beginning after the first treatment that continued to increase over time. Efficacy was further demonstrated in investigator visual analogue score evaluations and in high patient satisfaction ratings.

In 327 treatments, there were 30 "related" adverse events, of which burns/blistering were most common (14 events). Notably, the majority of patients rated treatment-related pain/discomfort as absent or only slight even though the procedures were performed without any anesthesia. Only 2 percent or fewer patients reported severe pain at any session and none considered the treatments intolerable.

"Pain has been a significant feature of other radiofrequency-based treatment modalities, and so the ability to achieve tissue tightening while minimizing treatment-related discomfort is an important advance. We will continue to follow these patients and will be expanding our investigations to include larger patient groups and to determine if the outcomes can be enhanced with different treatment parameters," Dr. Gold said.

FACES is performed with Dr. Gold and Dr. Goldman are stockholders, consultants, perform research, and lecture for Lumenis.

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